Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355680
• Other study ID #: 2PR1210511
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2006
• Last updated: February 10, 2009
• Start date: December 2005
• Est. completion date: July 2006

Study information

• Verified date: February 2009
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.

Description:

Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.

In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients more than 18 years of age

• Eyes with proliferative diabetic retinopathy requiring laser photocoagulation

Exclusion Criteria:

• Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation

• Patients requiring more than two sessions of laser photocoagulation

• Patients who had undergone previous laser photocoagulation

• Patients who had undergone any previous vitreo-retinal surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• Green Laser (Aurolas, Aurolab)
Green laser developed by Aurolab
• Green Laser (Iridex)
Already available green laser

Locations

Country	Name	City	State
India	Arvind Eye Hospital	Madurai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
Aurolab	Raja Ramanna Centre for Advanced Technology (RRCAT)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pigmentation of burn		2 months, 4 months, 6 months post laser	No
Primary	Lateral spread of burn		2 months, 4 months, 6 months post laser	No
Primary	Regression of new vessels		2 months, 4 months, 6 months post laser	No
Secondary	Choroidal detachment		2 months, 4 months, 6 months post laser	Yes
Secondary	Retinal detachment		2 months, 4 months, 6 months post laser	Yes
Secondary	Tractional retinal detachment		2 months, 4 months, 6 months post laser	Yes
Secondary	Bruch's membrane rupture		2 months, 4 months, 6 months post laser	Yes